What is supplement substantiation?

Substantiation is the process of gathering and documenting scientific evidence that supports the health claims you make on your supplement labels and marketing materials. The FDA requires that all structure–function claims be truthful, non-misleading, and substantiated by competent and reliable scientific evidence — typically clinical trials on healthy human subjects.

How does Nutra Comp's AI analysis work?

Nutra Comp searches PubMed for clinical trials relevant to your ingredient, filters for studies on healthy human subjects with oral administration, and uses AI to extract key data: p-values, effect sizes, study design, population details, and conclusions. It distinguishes between across-group and within-group significance and ranks evidence strength with a confidence scoring system.

What data sources does Nutra Comp use?

Nutra Comp primarily searches PubMed/MEDLINE, the world's largest biomedical literature database maintained by the U.S. National Library of Medicine. We focus on peer-reviewed clinical trials, randomised controlled trials (RCTs), meta-analyses, and systematic reviews.

Are the generated claims FDA-compliant?

Yes. Nutra Comp generates structure–function claims in strict accordance with the FDA Small Entity Compliance Guide. All claims avoid explicit and implicit disease references. However, we recommend having your legal/regulatory team review the final output before use, as Nutra Comp is a tool to assist — not replace — professional compliance review.

How long does a typical ingredient search take?

Most ingredient searches complete within 5–15 minutes, depending on the volume of clinical literature available. Compare this to the typical manual process which can take 40–100+ hours per ingredient when done by a human compliance expert.

Can I export my reports?

Absolutely. All clinical evidence reports, structure–function claims, and substantiation memos can be exported as professional PDF documents. These are formatted for easy sharing with your legal team, regulatory reviewers, or business partners.

What does 'ingredient searches per month' mean?

Each search is one ingredient analysis — for example, searching 'Ashwagandha' or 'Vitamin D3'. The search generates a complete evidence report, claims, and substantiation memo for that ingredient. Your monthly allowance resets on your billing date.

When will Nutra Comp be available?

We're currently in private beta. Join the waitlist to get early access and be notified when we launch. Early waitlist members will receive priority access and special launch pricing.

Panax Ginseng: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Energy & Cognition

Typical Dosage

200–400 mg/day (standardised extract)

Common Forms

Standardised root extract (4–7% ginsenosides)

What Is Panax Ginseng?

Panax ginseng (Korean/Asian ginseng) is one of the most widely used adaptogens with thousands of years of traditional use. Its active compounds, ginsenosides, have diverse pharmacological effects on energy, cognitive function, immune modulation, and sexual health.

Mechanism of action: Ginsenosides interact with multiple molecular targets including steroid hormone receptors, nitric oxide synthase, and ion channels. They modulate the HPA axis, enhance cholinergic neurotransmission, and stimulate nitric oxide production for vasodilation.

Clinical Evidence Summary

Below are 5 key clinical studies on Panax Ginseng. Nutra Comp analyses 58+ studies in its full clinical evidence report.

Systematic review2018PMID: 30411529

Panax ginseng and cognitive performance: a systematic review

Population: 10 RCTs

Key finding: Ginseng supplementation improved working memory and reaction time in healthy adults (p<0.05).

Meta-analysis2017PMID: 29099763

Ginseng and fatigue reduction: meta-analysis

Population: 12 RCTs

Key finding: Ginseng significantly reduced fatigue scores compared with placebo (SMD -0.33, p=0.002).

RCT2017PMID: 28515951

Korean red ginseng and immune function

Population: 100 healthy adults

Key finding: Red ginseng (3 g/day for 12 weeks) significantly increased NK cell activity and reduced cold/flu incidence (p<0.05).

Meta-analysis2015PMID: 26362110

Ginseng and erectile function: a meta-analysis

Population: 7 RCTs, 349 men

Key finding: Korean red ginseng significantly improved erectile function scores (IIEF) vs. placebo (WMD: 3.0, p=0.007).

Systematic review2020PMID: 32268543

Panax ginseng and blood sugar: systematic review

Population: 8 RCTs

Key finding: Ginseng supplementation modestly reduced fasting glucose and improved insulin sensitivity in at-risk populations.

Evidence-Based Structure–Function Claims

Sample FDA-compliant structure–function claims generated by Nutra Comp, each linked to clinical evidence and scored for confidence.

“Supports healthy energy levels and reduces occasional fatigue”

Category: Energy · Confidence: 8/10

“Supports cognitive function and mental clarity”

Category: Cognitive · Confidence: 7/10

“Supports healthy immune system function”

Category: Immune · Confidence: 7/10

Get the full substantiation report for Panax Ginseng

Includes all 58+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

Join Waitlist for Full Access

Related Ingredients

Ashwagandha

34 studies · Stress & Anxiety

Rhodiola Rosea

28 studies · Fatigue & Stress

Maca Root

18 studies · Sexual Health

Key Terms

Randomised Controlled Trial (RCT)Standardised Extract Placebo Effect

Frequently Asked Questions

Is Panax ginseng FDA approved?

Panax ginseng is sold as a dietary supplement under DSHEA. It does not require FDA approval. It should not be confused with American ginseng (P. quinquefolius) or Siberian ginseng (Eleutherococcus), which are different species.

What are the most studied benefits?

The strongest evidence supports ginseng for fatigue reduction, cognitive performance, immune function, and sexual health in men.

What dosage is used in studies?

Most studies use 200–400 mg/day of extract standardised to 4–7% ginsenosides. Korean red ginseng studies often use 1–3 g/day of the whole root preparation.

Stop Spending Weeks on Substantiation

Nutra Comp generates full clinical evidence reports, FDA-compliant structure–function claims, and substantiation memos in minutes — not months.

Join the Waitlist